FDA 510(k) Application Details - K160960

Device Classification Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)   More FDA Info for this Device
510(K) Number	K160960
Device Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant	ENDOGASTRIC SOLUTIONS, INC. 18109 NE 76TH STREET SUITE 100 REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	STEVEN J HOFFMAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	05/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review